Breastmilk collection system

ABSTRACT

A breastmilk collection device includes breast contacting flange, a vacuum reservoir, flexible diaphragm separating the breast contacting flange and the vacuum reservoir, and a flange receiver between the breast contacting flange and the flexible diaphragm. The breast contacting flange has a wide portion for accepting the breast and a narrow portion. The flexible diaphragm is located between the narrow portion and the vacuum reservoir. The flexible diaphragm moves between a sealed configuration, in which the breast contacting flange is sealed off from the vacuum reservoir, and an open valve configuration, in which the flexible diaphragm acts as a one-way valve to allow expressed milk to flow through a milk flow opening between the flexible diaphragm and the breast contacting flange when an opening pressure is reached in the breast contacting flange.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSerial Nos. 63/090,990, filed Oct. 13, 2020, and titled “BreastmilkCollection System,” and 63/106,132, filed Oct. 27, 2020, also titled“Breastmilk Collection System.” The above-referenced provisional patentapplications are hereby incorporated by reference in this application.

BACKGROUND

Breastmilk contains all the nutrients a baby needs for the first sixmonths of life to support growth and development. Therefore,breastfeeding and/or breastmilk feeding is recommended globally by theWorld Health Organization and healthcare professionals. When possible,mothers should be supported to initiate breastfeeding within the firsthour of their baby's life, breastfeed exclusively for six months, andcontinue breastfeeding while giving appropriate complementary foods forup to two years of age or beyond. There are situations, however, whendirect breastfeeding is not possible. For example, babies may not beable to latch and suckle, due to cleft palate or tongue tie,prematurity, low birthweight, or other causes, and mothers may not beable to breastfeed, due to medical conditions or recovery from birthtrauma. In such cases, human breastmilk feeding becomes the next bestoption. The principle methods used by mothers to collect humanbreastmilk are hand expressing breastmilk into a container andexpressing breastmilk using a manual or electric breast pump. For manymothers, a breast pump plays a significant role in the breastmilkfeeding process. Unfortunately, breast pumps are often cumbersome,obtrusive, noisy and inconvenient to carry from place to place and use.

Breast pump discretion and mobility are poorly met needs. Traditionalbreast pump systems use collection kits that include breast flanges andbottles. Although effective, these systems do not support discretion,mobility or ease of use and assembly. More recent systems use pumpsystems and/or collection cups that fit inside a breast pumping mother'sbra but include at least five components, not including tubing or asuction source. These systems tend to be difficult to use andcomplicated to assemble. Therefore, there is a distinct need for abreastmilk expression system that is more convenient, comfortable andunobtrusive. Ideally, such a system would facilitate emptying as muchbreastmilk as possible from a breast, to increase milk supply andminimize risk of breast engorgement. Also ideally, the system would berelatively easy to use, require only minimal/simple assembly, wouldenable a woman to express milk discretely, and would provide for easiermobility.

SUMMARY OF THE INVENTION

Regularly expressing breastmilk, whether by nursing or pumping, is acritical factor for mothers to establish and maintain breastmilk supply,even if an infant is not nursing at all or not nursing well. Thisdisclosure describes a device and system that offers flexibility andconvenience for pumping and collecting expressed breastmilk. In someembodiments, the device fits in a brassiere and is attached to anelectric pump using silicone tubes for applying vacuum to the device'spump. In other embodiments, the pump is directly attached to the device.The breastmilk collection device, securely supported by a brassiere,becomes a hands-free device that enables the lactating mother to pumpand/or collect expressed milk without holding the device. It also allowsa woman to pump and collect expressed breastmilk from one breast whilebreastfeeding an infant on the other breast.

In one aspect of the present disclosure, a breastmilk collection deviceincludes a breast contacting flange having a wide portion for acceptingthe breast and a narrow portion, a vacuum reservoir, a flexiblediaphragm separating the narrow portion of the breast contacting flangeand the vacuum reservoir, and a flange receiver coupled with the narrowportion of the breast contacting flange, between the flexible diaphragmand the breast contacting flange. The flexible diaphragm is configuredto move between a sealed configuration, in which the breast contactingflange is sealed off from the vacuum reservoir, and an open valveconfiguration, in which the flexible diaphragm acts as a one-way valveto allow expressed milk to flow through a milk flow opening between theflexible diaphragm and the flange receiver when an opening pressure isreached in the breast contacting flange.

In some embodiments, the breastmilk collection device also includes acup attached to the wide portion of the breast contacting flange. Thecup has a first portion that forms a milk container and a second portionthat forms the vacuum reservoir. The cup may also include a suction tubeattachment port in fluid communication with the vacuum reservoir.Optionally, the cup may also include measurement lines to measure milkstored in the milk storage compartment. In some embodiments, the devicealso includes a breast pump attached to the cup. In some embodiments,the breast pump is removably attached to the cup. Alternatively, thebreast pump may be located inside the storage compartment. Such aninternal pump may include a printed circuit board and a power source.Some embodiments may further include tubing for connecting the breastpump to an additional wearable breastmilk collection device, such thatthe wearable breastmilk collection device and the additional wearablebreastmilk collection device can be worn at the same time and usedsimultaneously or sequentially.

In some embodiments, the flexible diaphragm forms a seal with the flangereceiver in the sealed configuration, and a portion of the flexiblediaphragm unseals from the flange receiver to allow the expressed milkto flow out of the milk flow opening between the flexible diaphragm andthe flange receiver. The flange receiver has an opening into which thenarrow portion of the breast contacting flange fits for attachment, andthe flexible diaphragm is attached to a side of the flange receiver thatis opposite the breast contacting flange. In some embodiments, theflange receiver and the breast contacting flange are one piece.

In some embodiments, the device further includes an adapter attached tothe flange receiver and/or the narrow portion of the breast contactingflange. The adapter typically forms the vacuum reservoir and houses theflexible diaphragm. The adapter may include a suction tube attachmentport in fluid communication with the vacuum reservoir. The adapter mayalso include a milk container attachment portion for attaching to a milkcontainer. In some embodiments, a flange connecting portion of theadapter is configured to move by tilting and/or rotating relative to themilk container attachment portion.

In manual embodiments, the device may also include a pull rod attachedto the flexible diaphragm and extending out of an opening on a back ofthe adapter and a handle attached to the adapter and the pull rod forpulling back on the pull rod to manually pull on the flexible diaphragmto generate vacuum force. Optionally, the pull rod may have two settingsdefining two different locations for attachment of the handle to thepull rod, to generate at least two different amounts of pulling force onthe flexible diaphragm.

In another aspect of the present disclosure, a method of expressing andcollecting breastmilk from a breast involves positioning the breastmilkcollection device described above on the breast and expressingbreastmilk from the breast, using the breastmilk collection device. Insome embodiments, positioning the breastmilk collection device on thebreast involves positioning the breastmilk collection device inside of abrassiere. Such a method may further involve attaching the breastmilkcollection device to a pump located outside of the brassiere. Attachingthe breastmilk collection device to the pump may involve attachingtubing from the pump to a vacuum source attachment port of thebreastmilk collection device that is in fluid communication with thevacuum reservoir.

Alternatively, the method may involve attaching the breastmilkcollection device to a pump located inside the brassiere. In otherembodiments, expressing breastmilk from the breast involves squeezing ahandle of the breastmilk collection device. The method may optionallyalso include adjusting a position of an attachment point of the handleto a pull rod of the breastmilk collection device to change an amount ofpulling force generated on the flexible diaphragm by the handle. Inother embodiments, the method involves attaching the breastmilkcollection device to an electric pump to express the breastmilk. Themethod may also involve attaching a milk container to the breastmilkcollection device to collect the expressed breastmilk.

In one aspect of the present disclosure, a wearable breastmilkcollection device includes a cup and a breast contacting flange attachedto the cup, where an inner space formed by the attached cup and breastcontacting flange serves as a milk storage compartment. The breastcontacting flange may include a first opening for allowing vacuum forceto enter the breast contacting flange and a second opening for allowingexpressed milk to exit the breast contacting flange. The device alsoincludes flexible diaphragm in the vacuum reservoir, where vacuum forcegenerated by the flexible diaphragm is transmitted into the breastcontacting flange via the first opening, and a one-way valve locatedbetween the second opening on the breast contacting flange and the milkstorage compartment.

In some embodiments, the vacuum reservoir has a dome shape or ahalf-dome shape. In some embodiments, the vacuum reservoir is housedcompletely within the milk storage compartment, while in others thevacuum reservoir protrudes out of the cup or a portion of the cup formsa wall of the vacuum reservoir. In some embodiments, the device alsoincludes a vacuum source attachment port in fluid communication with thevacuum reservoir for attaching with tubing from an external breast pump.

Optionally, the device may include a flange receiver attached to thevacuum reservoir, the one-way valve and the breast contacting flange.The flange receiver may include a lower vacuum communication wallleading to the first opening of the breast contacting flange. In someembodiment, the one-way valve is formed by a contact point between theflange receiver ad the flexible diaphragm. Alternatively, the one-wayvalve may be a duck-bill valve or any other suitable form of one-wayvalve. In some embodiments, the cup may include measurement lines tomeasure milk stored in the milk storage compartment.

Some embodiments further include a breast pump attached to the cup. Thebreast pump may be removably attached to the cup. The breast pump may belocated inside the storage compartment and may include a printed circuitboard and a power source. Some embodiments may include tubing forconnecting the breast pump to an additional wearable breastmilkcollection device, such that the wearable breastmilk collection deviceand the additional wearable breastmilk collection device can be worn atthe same time and used simultaneously or sequentially.

In another aspect of the present disclosure, a breastmilk collectiondevice includes a breast contacting flange, a milk container, an adaptercomprising a flange connecting portion and a milk container connectingportion, a flexible diaphragm in the adapter, a vacuum source attachmentport on the adapter, and a reservoir between the flexible diaphragm andthe vacuum source attachment port. Vacuum force is transmitted throughthe vacuum source attachment port and the vacuum reservoir to move theflexible diaphragm and thus generate vacuum force in the breastcontacting flange.

In some embodiments, the milk container is a bottle. Some embodimentsmay include a flange receiver in the adapter, attached on one side tothe flexible diaphragm and on an opposite side the breast contactingflange. In some embodiments, the flange connecting portion of theadapter is configured to tilt relative to the milk container connectingportion. In some embodiments, the flange connecting portion of theadapter is configured to rotate relative to the milk containerconnecting portion.

In another aspect of the present disclosure, a breastmilk collectiondevice includes a breast contacting flange, a milk container, an adaptercomprising a flange connecting portion and a milk container connectingportion, a flexible diaphragm in the adapter, a pull rod attached to thediaphragm, and a handle attached to the adapter and the pull rod forpulling back on the pull rod to manually pull on the flexible diaphragmto generate vacuum force. Vacuum force generated by the flexiblediaphragm is transmitted into the breast contacting flange. Optionally,the pull rod may include two bulbs, and herein the handle is adjustablein its attachment to the pull rod to be located in at least twodifferent locations relative to the two bulbs, to generate at least twodifferent amounts of pulling force on the flexible diaphragm. The devicemay include a flange receiver in the adapter, attached on one side tothe flexible diaphragm and on an opposite side the breast contactingflange.

In another aspect of the present disclosure, a method of expressing andcollecting breastmilk from a breast involves positioning a wearablebreastmilk collection device on the breast, inside of a brassiere, andexpressing breastmilk from the breast, using the wearable breastmilkcollection device. The wearable breastmilk collection device may haveany of the components and features described above. In some embodiments,the method involves attaching the wearable breastmilk collection deviceto a pump located outside of the brassiere. In other embodiments, themethod involves attaching tubing from the pump to a vacuum sourceattachment port of the wearable breastmilk collection device that is influid communication with the vacuum reservoir. The method may alsoinvolve attaching the wearable breastmilk collection device to a pumplocated inside the brassiere.

In another aspect of the present disclosure, a method of expressing andcollecting breastmilk from a breast involves positioning a manualbreastmilk collection device on the breast and using a handle of thedevice to express breastmilk from the breast. The manual breastmilkcollection device includes a breast contacting flange, a milk container,an adapter comprising a flange connecting portion and a milk containerconnecting portion, a flexible diaphragm in the adapter, a pull rodattached to the diaphragm, and a handle attached to the adapter and thepull rod for pulling back on the pull rod to manually pull on theflexible diaphragm to generate vacuum force.

In some embodiments, the method further involves adjusting a position ofan attachment point of the handle to the pull rod to change an amount ofpulling force generated on the flexible diaphragm by the handle. Themethod may also involve noting an amount of milk in the milk containerby viewing a fluid level of the milk relative to fluid level measurementlines on the milk container and removing the milk container from theadapter. Using the handle may involve compressing the handle with thehandle in a first attachment position relative to the pull rod tostimulate the breast and compressing the handle with the handle in asecond attachment position relative to the pull rod to express milk fromthe breast.

According to various embodiments, the breastmilk collection systemdescribed herein includes a breast contacting flange, a flange receiver,and a flexible diaphragm and a breastmilk collection container that useselectric vacuum power source for pumping. The opening side of a funnelshaped breast flange that is applied to the breast may be formed as alid to a cup shaped collection container to secure collected expressedbreastmilk inside the container. A funnel shaped breast flange isinserted into a flange receiver and assembled with a valve to letexpressed human breastmilk drip into the collection container. A breastflange tunnel can be narrower or wider to work with different sizes ofnipples. Some embodiments may include a check valve integration of aflange receiver and a valve to minimize the risk of improper assemblyand misuse. A check valve allows reduction of a number of parts forconvenience and to make a collection device compact.

These and other aspects and embodiments are described in further detailbelow, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side, cross-sectional view of a breastmilk collectiondevice, according to one embodiment;

FIG. 1B is an exploded view of the breastmilk collection device of FIG.1A;

FIG. 2A is a side, cross-sectional view of a breastmilk collectiondevice, according to an alternative embodiment;

FIG. 2B is an exploded view of the breastmilk collection device of FIG.2A;

FIG. 3A is a side, cross-sectional view of a breastmilk collectiondevice, according to an alternative embodiment;

FIG. 3B is an exploded view of the breastmilk collection device of FIG.3A;

FIG. 4A is a side/perspective, cross-sectional view of a breastmilkcollection device, according to an alternative embodiment;

FIG. 4B is an exploded view of the breastmilk collection device of FIG.4A;

FIGS. 4C and 4D are partial cross-sectional views of the breastmilkcollection device of FIGS. 4A and 4B, illustrating a path for milk flowthrough the device;

FIGS. 5A-5C are perspective, side and rear views, respectively, of abreastmilk collection device with an electric pump, according to oneembodiment;

FIG. 5D is a partial perspective view of the breastmilk device of FIGS.5A-5C, illustrating an optional light for nighttime visualization;

FIGS. 6A-6C are side, partial cross-section and exploded views,respectively, of a breastmilk collection device with an electric pump,according to an alternative embodiment;

FIGS. 7A and 7B are top views of a breastmilk collection device with anelectric pump, according to an alternative embodiment, illustratingoperation of an optional light;

FIGS. 8A-8C are rear views of three alternative embodiments of abreastmilk collection device with an internal electric pump, where thepump is located in different positions;

FIG. 8D is a side view of a breastmilk collection device with anelectric pump, illustrating operation of an optional light;

FIGS. 9A-9C are side/cross-sectional, rear and exploded views,respectively, of a breastmilk collection device with a removable milkcontainment device, according to another alternative embodiment;

FIG. 9D is a close-up view of a portion of FIG. 9A;

FIGS. 9E and 9F are close-up views of another portion of the breastmilkcollection device of FIGS. 9A-9D, illustrating a path for milk flowthrough the device;

FIG. 9G is a side, cross-sectional view of the breastmilk collectiondevice of FIGS. 9A-9F, illustrating the ability of a portion of thedevice to tilt;

FIG. 9H is two perspective views of a top portion of the breastmilkcollection device of FIGS. 9A-9G, illustrating the ability of a portionof the device to rotate;

FIGS. 10A-10C are side/cross-sectional, front and rear views,respectively, of a wearable breast milk collection device, according toone embodiment;

FIGS. 11A-11C are side/cross-sectional, front and rear views,respectively, of a wearable breast milk collection device, according toan alternative embodiment;

FIG. 12 is a side, cross-sectional view of a wearable breastmilkcollection device with a built-in pump and driven by electromechanicalactuation of components, according to one embodiment;

FIG. 13 is a side, cross-sectional view of a wearable breastmilkcollection device with a built-in pump and driven by electromechanicalactuation of components, according to an alternative embodiment;

FIG. 14 is a front facing view of a wearable breastmilk collectionsystem for double pumping, including a pump directly attached to onebreastmilk collection device and indirectly to a second collectiondevice via a suction connection tube; and

FIG. 15 is a perspective and exploded view of a wearable breastmilkcollection device with a flexible diaphragm and a duckbill valve,according to one embodiment;

FIG. 16 is a perspective and exploded view of a wearable breastmilkcollection device with a flexible diaphragm with a tab, according to analternative embodiment;

FIG. 17 is a perspective and exploded view of a wearable breastmilkcollection device with a flexible diaphragm, according to anotheralternative embodiment; and

FIGS. 18A-18D are side/cross-sectional, partial rear, side and partialperspective views, respectively, of a manual breastmilk collectiondevice with a handle, according to one embodiment.

DETAILED DESCRIPTION

Embodiments described herein include both wearable breast pump devicesand portable devices that are not wearable. Each embodiment includes oneor more new and improved components or features, as compared tocurrently available breast pumps, to facilitate wearability, portabilityand/or breast milk expression and collection.

FIGS. 1A and 1B illustrate one embodiment of a wearable breastmilkcollection device 100 that is worn within a woman's brassier whilecollecting milk. FIG. 1A is a side, cross-sectional view, and FIG. 1B isan exploded view. As with all of the embodiments described herein, thecollection device 100 may be used as part of any breast pump system, andit is not limited to use with any particular system.

In this embodiment, the wearable breastmilk collection device 100includes a milk storage compartment 101 that is formed by a breastcontacting flange 102 coupled with a cup 112 and is separated from thebreast contacting flange 102 by a one-way valve 103, such as but notlimited to a duckbill valve. The collection device 100 is operated undervariable suction parameters of vacuum through an external vacuum sourceattachment port 104 that provides suction to an vacuum reservoir 113formed by a half dome 105 attached to a flexible diaphragm 106. Thevacuum reservoir 113 is created by compressing the half dome 105 againstthe flexible diaphragm 106 and a flange receiver 111, which includes alower vacuum communication wall with an outlet into an upper opening 116on the breast contacting flange 102. Communication of suction force fromthe vacuum reservoir 113 to the breast contacting flange 102 is achievedthrough the flexible diaphragm 106. Vacuum force is actuated from theflexible diaphragm 106 in cycles, which helps to extract milk orcolostrum from the breast. Milk flows from the breast through a loweropening 118 on the breast contacting flange 102 and into a collectioncompartment 107 anterior to the one-way valve 103. The wearablebreastmilk collection device 100 may optionally include horizontal 108and/or vertical 109 measurement lines, to help the user determine thevolume of fluid contained within the wearable breastmilk collectiondevice 100 if the cup 112 was in place on the breast vertically orplaced on the table in the prone position with a flat resting edge 110touching the table.

FIG. 1B shows the components of the wearable breastmilk collectiondevice 100 in exploded view. Again, the cup 112 attaches to the breastcontacting flange 102 to form the storage compartment 101. The wide openend of the breast contacting flange 102 is configured to accept thewoman's breast for milk collection. The flange receiver 111 and thecollection compartment 107 may be one piece, with the diaphragm 106fitting into the flange receiver 111 and the one-way valve 103 fittingonto the end of the collection compartment 107. The half dome 105 withits vacuum source attachment port 104 fits on top of and over the edgesof the flange receiver 111 and the diaphragm 106. The vacuum sourceattachment port 104 extends through an opening 120 on the top of the cup112, when the collection device 100 is assembled. All the parts of thecollection device 100 may be made of any suitable material orcombination of materials. For example, some or all of the parts may bemade of one or more plastics. The diaphragm 106 may be made of aflexible rubber material. The breast contacting flange 102 may be madeout of a polymer designed to interact comfortably with the woman'sbreast. Again, any suitable materials may be used in the construction ofthe collection device 100. The various parts may be attached to oneanother using glue, other adhesive material, press fit, snap fit or anyother suitable attachment mechanism(s).

In use, the breast contacting flange 102 is placed over the woman'sbreast. Suction tubing (not illustrated) is attached to a breast pump(not illustrated) at one end and to the vacuum source attachment port104 at an opposite end. When the breast pump is activated, suction forceis transmitted from the breast pump through the suction tubing to thevacuum source attachment port 104 and thus into the vacuum reservoir113. This suction force pulls up on the diaphragm 106 and thus transmitssuction force via the upper opening 116 into the interior, breastcontacting portion of the breast contacting flange 102. This suctionforce helps express milk from the breast. Expressed milk travels throughthe lower opening 118 on the breast contacting flange 102 and into thecollection compartment 107 and then through the one-way valve 103 andinto the storage compartment 101. Back pressure in the collection device100, along with gravity, helps pull the expressed milk through theone-way valve 103.

FIGS. 2A and 2B illustrate an alternative embodiment of a wearablebreastmilk collection device 200. FIG. 2A is a side, cross-sectionalview, and FIG. 2B is an exploded view. The wearable breastmilkcollection device 200 includes a storage compartment 201 formed by thecoupling of a breast contacting flange 202 with a cup 212. The cup 212is separated from the breast contacting flange 202 by a one-way valve203, such as but not limited to a duckbill valve. The collection device200 is operated under variable suction parameters of vacuum through anexternal vacuum source attachment port 204 positioned on a half dome205, to provide suction to an vacuum reservoir 206. The vacuum reservoir206 is formed by compressing the half dome 205 against a flexiblediaphragm 207 and is securely locked by a receptacle 209 of the cup 212to form a complete seal to store expressed breastmilk. Below theflexible diaphragm 207 is a flange receiver 208 that has a lower vacuumcommunication wall with an outlet into an upper opening 216 on thebreast contacting flange 202. Communication of suction force from thevacuum reservoir 206 to the breast contacting flange 202 is achievedthrough the flexible diaphragm 207. Vacuum force is actuated from theflexible diaphragm 207 in cycles, which helps to extract milk orcolostrum from the breast and allow it to flow through a lower opening218 the breast contacting flange 202 into a collection compartment 214anterior to the one-way valve 203. The wearable breastmilk collectiondevice 200 may optionally include horizontal 210 and/or vertical 211measurement lines to help the user determine the volume of fluidcontained within the wearable breastmilk collection device 200 if thecup 212 was in place on the breast vertically or placed on the table inthe prone position with a flat resting edge 213 touching the table. Anyof the features and details described above in relation to one or moredifferent embodiments may also be applied to this embodiment.

FIGS. 3A and 3B illustrate another alternative embodiment of a wearablebreastmilk collection device 300. FIG. 3A is a side, cross-sectionalview, and FIG. 3B is an exploded view. The wearable breastmilkcollection device 300 includes a storage compartment 301 formed by thecoupling of a breast contacting flange 302 and a cup 310. The storagecompartment 301 and separated from a breast contacting flange 302 by aone-way valve 303, such as but not limited to a duckbill valve. Thecollection device 300 is operated under variable suction parameters ofvacuum through an external vacuum source attachment port 304 on the cup310 that provides suction to an vacuum reservoir 305. The vacuumreservoir 305 is formed by attachment of the cup 310 to the flexiblediaphragm 306, which in turn is securely locked into a receptacle 307,which is also part of the cup 310 and thus has one fewer component thanthe previously described embodiment. A flange receiver 308 includes alower vacuum communication wall with outlet into the opening of thebreast contacting flange 302. Communication of the suction force fromthe vacuum reservoir 305 to the breast contacting flange 302 is achievedthrough the flexible diaphragm 306 and through an upper opening 316 onthe breast contacting flange 302. Vacuum force is actuated from theflexible diaphragm 306 in cycles, which helps extract milk or colostrumfrom the breast and allow it to flow through a lower opening on thebreast contacting flange 302 into a collection compartment 309 anteriorto the one-way valve 303. Any of the features and details describedabove in relation to one or more different embodiments may also beapplied to this embodiment.

FIGS. 4A and 4B illustrate another alternative embodiment of a wearablebreastmilk collection device 400. FIG. 4A is a side/perspective,cross-sectional view, and FIG. 4B is an exploded view. The wearablebreastmilk collection device 400 includes a collection receptacle 401(or “cup”), a breast contacting flange 402, a flange receiver 403 and aflexible diaphragm 404 that acts as a one-way valve. The cup/collectionreceptacle 401 includes a vacuum source attachment port 411, which is influid communication with a vacuum reservoir 410. A milk storagecompartment 405 that receives the expressed breastmilk is formed by theinward facing walls of the collection receptacle 401, the breastcontacting flange 402 and diaphragm 404. The milk storage compartment405 is created by coupling the breast contacting flange 402 with thecollection receptacle 401 and is separated from the breast contactingflange 402 by the flexible diaphragm 404. The vacuum reservoir 410 is aseparate area formed by the collection receptacle 401 behind theflexible diaphragm 404 and sealed off from the milk storage compartment405, so that milk does not enter the vacuum reservoir. The breastcontacting flange 402 has a wide portion 402 a at the outward facingend, into which the woman places her breast, and tapers down to a narrowportion 402 b, which attaches to the flange receiver 403.

Referring to FIGS. 4C and 4D, the flexible diaphragm 404 includes anintegrated one-way valve 406, which may be a flapper valve, as in thisembodiment, or any other suitable type of valve. In some embodiments,the one-way valve 406 is an outer rim of the flexible diaphragm 404. Inother embodiments, the one-way valve 406 may be a tab or other extensionoff of the flexible diaphragm 404. The one-way valve 406 contacts theflange receiver 403 and the collection receptacle 401 to form an innerseal 407 and outer seal 408. The flexible diaphragm 404 is capturedbetween the flange receiver 403 and the collection receptacle 401, whosehalf dome top 409 forms the vacuum reservoir 410 with the flexiblediaphragm 404. The vacuum reservoir 410 is created by compressing theflange receiver 403 against the flexible diaphragm 404 and thecollection receptacle 401. In some embodiments, as in FIGS. 4A-4D, theone-way valve 406 is formed by contact between the flexible diaphragm404 and the flange receiver 403. In alternative embodiments, the one-wayvalve 406 may be formed by contact between the flexible diaphragm 404and the breast contacting flange 402.

The wearable breastmilk collection device 400 is operated under variablesuction parameters of vacuum, applied by an electric breast pump (notillustrated), connected via suction tubing to the vacuum sourceattachment port 411, which provides suction to the vacuum reservoir 410.Communication of the suction force from the vacuum reservoir 410 to thebreast contacting flange 402 is achieved through the flexible diaphragm404. Vacuum force is actuated from the flexible diaphragm 404 in cycles,which helps to extract milk or colostrum from the breast and allow it toflow into the storage compartment 405 anterior to the one-way valve 406.The flow path 412 from the breast contacting flange 402 to the storagecompartment 405 includes the flow entrance 413, located at the distalend of the breast contacting flange 402, flow chamber 414 and flow exit415. As air is pushed back into vacuum reservoir 410 and milk flows intothe storage compartment 405, air is displaced and exits through a venthole 420, which may optionally include a float restrictor or valve toprevent spillage through the vent hole 420 when a user bends over. Somesystems may not need a vent hole 420, if the amount of displaced airvents around another part of the seal mechanism above the liquid level.

To ensure proper flow, an alignment mechanism is included, which alignsthe breast contacting flange 402, the collection receptacle 401 and theflange receiver 403. During assembly, the flange receiver 403 is pressedonto the breast contacting flange 402, and a slot 418 on the breastcontacting flange 402 accepts a post 419 on the flange receiver 403. Asecuring feature 416 on the collection receptacle 401 is also placedinto a receiving feature 417 on the breast contacting flange 402, priorto pressing the breast contacting flange 402 onto the collectionreceptacle 401.

FIGS. 5A-5D illustrate another alternative embodiment of a wearablebreastmilk collection device 500. The wearable breastmilk collectiondevice 500 includes an external breast pump 501 attached to a collectionreceptacle 502 (or “cup”). The collection device 500 is operated undervariable suction parameters of vacuum by the external breast pump 501and is connected to an external vacuum source attachment 504 by a pumpconnecter 505. Using the pump connector 505 gives a pumping mother theoption of using different external breast pumps.

FIGS. 6A-6C illustrate a wearable breastmilk collection device 500 wherethe wearable breastmilk collection device 500 includes an externalbreast pump 501 that is removably attachable to a collection receptacle502. In this instance the pump is connected directly to the vacuumreservoir 511 by the vacuum communication conduit 506. The collectiondevice 500 is operated under variable suction parameters of vacuum bythe external breast pump 501 and is connected to vacuum communicationconduit 506 such that it provides suction to an vacuum reservoir 511.The vacuum reservoir 511 is created by pressing the external breast pump501 into the pump connection cylinder and compressing the flexiblediaphragm 509 to the half dome top 510.

FIG. 7A illustrates a wearable breastmilk collection device 500 wherethe wearable breastmilk collection device 500 includes an externalbreast pump 501 that is located below the targeted nipple location 513,enabling visualization, supporting consistent nipple placement andoverall proper use.

FIG. 7B illustrates a wearable breastmilk collection device 500 wherethe wearable breastmilk collection device 500 includes an externalbreast pump 501 that is located below the targeted nipple location 513and a light 508 that can be switched on and off, facilitatingvisualization and supporting consistent nipple placement and overallproper use.

FIGS. 8A-8C illustrate a wearable breastmilk collection device 500 forcollection of breastmilk from a mother by being placed in her brassier,such that when the device is in use the mother can be hands-free. Thewearable breastmilk collection device 500 includes an internal breastpump 512 that is located within the collection receptacle 502, but notin direct communication or contact with the collected breastmilk. Theinternal breast pump 512 can be located in multiple different positionswhile still enabling better visualization and supporting consistentnipple placement and overall proper use.

FIG. 8D describes a wearable breastmilk collection device 500 where thewearable breastmilk collection device 500 includes an internal breastpump 512 such that a breast pump is an electromechanical device thatgenerates a oscillating suction wave that is located below the targetednipple location 513 and a light 508 that can be switched on and offenabling better visualization and supporting consistent nipple placementand overall proper use.

FIGS. 9A-9E illustrate another embodiment of a breastmilk collectionsystem 600. The breastmilk collection system 600 includes a milkcollection receptacle 601, a breast contacting flange 602, a flangereceiver 603, a flexible diaphragm 604 and an adapter 605. The adapter605 includes a flange attaching portion 610 for connecting to the breastcontacting flange 602 and a receptacle attaching portion 622 forconnecting to the collection receptacle 601. In some embodiments, thebreastmilk collection system 600 may be provided without the collectionreceptacle 601, which may be sold separately. As best seen in thecross-section of FIG. 9D, the flange attaching portion 610 of theadapter 605 has a half-dome shape and includes a vacuum sourceattachment port 612, for connecting to one end of suction tubingconnected to an electric breast pump (tubing and pump not shown). Aspace formed inside the half dome of the flange attaching portion 610,between its inner wall and the flexible diaphragm 604, acts as a vacuumreservoir 611, which is in fluid communication with the vacuum sourceattachment port 612. The flange receiver 603 is attached to the flangeattaching portion 610 such that the flexible diaphragm 604 residesbetween the vacuum reservoir 611 and the flange receiver 603. As inpreviously described embodiments, the breast contacting flange 602 has awide, breast accepting portion 602 a and a narrow portion 602 b attachedto the flange receiver 603.

Referring to FIGS. 9E and 9F, the flexible diaphragm 604 includes anintegrated one-way valve 607, similar to the one-way valve described inrelation to FIGS. 4C and 4D. The flexible diaphragm 604 is locatedbetween, and directly connected to, the flange receiver 603 and theflange attaching portion 610 of the adapter 605. This connection createsboth an inner seal 608 and outer seal 609. As mentioned above, theflexible diaphragm 604 is captured between the flange receiver 603 andthe flange attaching portion 610, thus forming the vacuum reservoir 611.The vacuum reservoir 611 is created by compressing the flange receiver603 against the flexible diaphragm 604 and the adapter 605.

The breastmilk collection system 600 operates under variable suctionparameters of vacuum via the vacuum source attachment port 612 thatprovides suction to the vacuum reservoir 611. Suction force istransmitted from the vacuum reservoir 611 to the breast contactingflange 602 via the flexible diaphragm 604. Vacuum force is actuated fromthe flexible diaphragm 604 in cycles, which helps extract milk orcolostrum from the breast and allows the milk or colostrum to flow intothe collection receptacle 601 anterior to the one-way valve 607. A flowpath 613 from the breast contacting flange 602 to the collectionreceptacle 601 includes a flow entrance 614, located at the distal endof the breast contacting flange 602, a flow chamber 615 and a flow exit616.

Referring now to FIGS. 9G and 9H, in some embodiments, the adapter 605may include one or more adjustment features, for example to allowadjustment of the flange attaching portion 610 relative to thereceptacle attaching portion 622. This adjustability may facilitate amore comfortable pumping position for the woman using the system 600.FIG. 9G illustrates a tilting mechanism 617 that allows the user to tiltthe flange attaching portion 610 relative to the receptacle attachingportion 622 and thus change the angle of the breast contacting flange602 angle relative to the collection receptacle 601. FIG. 9H illustratesa rotation mechanism 618 that allows the user to rotate the flangeattaching portion 610 relative to the receptacle attaching portion 622.An optional bottle vent hole 619 on the top of the receptacle attachingportion 622 is also shown—it allows air displaced by the movement ofmilk or colostrum into the collection receptacle 601 to be vented.

FIGS. 10A-10C illustrate another alternative embodiment of a wearablecollection cup 700 for collection of breastmilk from a mother. Thisembodiment may include all of the components described for embodimentsabove, such as a flexible diaphragm, a flange receiver and a vacuumreservoir, although not all features are labeled. In this embodiment,the wearable collection cup 700 includes either an external breast pump704 (FIG. 10B, shown with optional light 705) that is attachable to acollection receptacle 702 or an internal breast pump 706 (FIG. 10C). Thecollection receptacle 702 has a visualization recess 703 that comes inclose proximity to the area where the wide portion 708 of the breastcontacting flange 701 intersects with the narrow portion 709. Thevisualization recess 703 is located on the upper, outer portion of thecollection receptacle 702, enabling better visualization and supportingconsistent nipple placement and overall proper use.

FIGS. 11D-11F illustrate another alternative embodiment of a wearablecollection cup 700 for collection of breastmilk from a mother. Thewearable collection cup 700 contains either an external breast pump 704and light 705 that is attachable to a collection receptacle 702 or aninternal breast pump 706 and light 705. The collection receptacle 702has a visualization lens 707 located in the upper portion of thecollection receptacle 702. The visualization lens could be molded intothe collection receptacle or could be a separate component that isjoined to the collection receptacle 702. The visualization lens 703 islocated on the upper, outer portion of the collection receptacle 702enabling better visualization and supporting consistent nipple placementand overall proper use.

Referring now to FIG. 12, in another alternative embodiment, a wearablebreastmilk collection device 800 has an integrated breast pump,including a solenoid coil 802, with a magnetic core 801, such as softiron, to concentrate a magnetic field, and an armature 803, also made ofa magnetic core or magnet integrated into a diaphragm 804. When currentis passed through the coil 802, a magnetic field is created, which isconcentrated into the magnetic core 801. This will attract the armature803, thus pulling the diaphragm 804 in, creating a vacuum in a breastcontacting flange 806. A vent hole 805 helps equalize pressure acrossthe device when the solenoid is on. When current is turned off, thediaphragm 804 acts as a spring to return the armature 803 back toinitial position, thus releasing the pressure within the flange 806without the use of another solenoid as in a typical breast pump. Aprinted circuit board (PCB) 807 (including a control unit) and a battery808 are used to control and power the breast pump. In an alternativeembodiment, the armature 803 is not embedded into the diaphragm, butrather may be attached to a piston.

Referring now to FIG. 13, an alternative embodiment of a wearablebreastmilk collection device 810 with an integrated breast pump isillustrated. In various embodiments, the integrated breast pump mayinclude a linear actuator, such as a voice coil actuator, moving magnetactuator or moving coil actuator. The breastmilk collection device 810of FIG. 13 includes a moving coil actuator. The moving coil actuatorincludes a yoke 811 made of magnetic core, with a permanent magnet 812attached. A bobbin 813 (or “coil holder”) has a wire coil 814 woundaround it, and the bobbin 813 acts as a piston with rubber gasket 817 toensure an air-tight seal. As current passes through the wire coil 814, alateral force is created, which drives the bobbin 813 (piston) left andright. As the bobbin 813 moves left and right, because of the air-tightseal, a diaphragm 815 moves along with it, thus generating a vacuumforce on a breast contacting flange 819. A vent hole 816 helps equalizepressure when the bobbin 813 moves back and forth. A sensor 818, such asa hall-effect sensor or pressure sensor, can provide feedback resultingin the bobbin 813 operating in a closed-feedback loop. This allows forprecise control of the vacuum created in the flange 819. The precisecontrol of the piston/bobbin movement also allows the breast pump tocreate micro-vibrations in the vacuum waveform to aid letdown. Torelease the vacuum in the flange 819, the current is reversed, causingthe bobbin 813 to move in the opposite direction, thus releasing thevacuum in the flange 819. A PCB 820 (including a control unit) and abattery 821 are included to control and power the breast pump. Thisdesign also does not require an additional solenoid, as required in atraditional breast pump design. In an alternative embodiment, the bobbin813 does not need to be a separate component. The wire coil 814 can beembedded into the diaphragm 815, similar to the diaphragm 804 of thepreviously described embodiment.

FIG. 14 illustrates a breastmilk collection system that includes twobreastmilk collection devices 900 collecting milk from both breastssimultaneously or sequentially. In this system, either cup 900 can beinterchangeably or uniquely detached or attached to a source of suction,such as an electromechanical vacuum pump 902, which may includecomponents such as a PCBA, vacuum motor, battery, and/or othercomponents such as buttons, Bluetooth antennas or other signalingsystems, LCD or other display, or other mechanisms such as would beneeded for a user to operate the system including a button or featurethat enables the user to pump left side only, right side only, or bothsides simultaneously with or without a time out feature such as a sleeptimer. One vacuum pump system 902 is connected to a first collection cup900 via a connection in the base or side of the vacuum pump system 902and to a second collection cup 900 via a connector tubing 901 that spansat least the distance between each of the cups if placed inside abrassier in operation. The connector tubing 901 connects the vacuum pumpsystem 902 to the second cup 900 via a connector port 904 on the secondcup 900, which transmits suction from the vacuum pump system 902 to thesecond collection cup 900. The pump 902 may also be wirelessly, NFC, RF,or Bluetooth connected or other signal service connected, such as butnot limited to 3G or 4G to a mobile device or a additional remotecontrol 905.

FIGS. 15-17 illustrate three exemplary embodiments of wearablebreastmilk collection devices 1000, 1010, 1020, each of which includes acup 1006, 1016, 1026 (or “milk collection receptacle”) and a breastaccepting flange 1001, 1011, 1021. In each embodiment, a wide open endof the cup 1006, 1016, 1026 attaches to a wide portion of the breastaccepting flange 1001, 1011, 1021 to form an inner compartment forstorage of milk and/or colostrum expressed from the breast. In theembodiment of FIG. 15, an internal valve system of the wearablebreastmilk collection device 1000 includes a flange receiver 1003, aduckbill valve 1004 and a pressure communicating flexible diaphragm1002. In the embodiment of FIG. 16, an internal valve system of thewearable breastmilk collection device 1010 includes an integratedpressure communicating flexible diaphragm 1015 with a bill flap and aflange receiver 1016 with a milk flow channel that leads from the breastcontacting flange 1011 into the storage compartment within the cup 1016.In the embodiment of FIG. 17, an internal valve system includes anintegrated pressure communicating flexible diaphragm 1027 and a flangereceiver 1028 with a milk flow channel that leads from the breastcontacting flange 1021 into the storage compartment within the cup 1026.In this embodiment, the flexible diaphragm 1027 has a rim with a uniformshape that eliminates orientation specific assembly.

FIGS. 18A-18D illustrate another embodiment of a breastmilk collectiondevice 1700. In this embodiment, the collection device 1700 is handheldand uses a manual pumping mechanism rather than a motorized pump. Thebreastmilk collection device 1700 includes a breast contacting flange1702, a flexible diaphragm 1704, a pull rod 1706, a handle 1712, anadaptor, and a milk bottle 1718 (or “milk collection receptacle”). Theadapter 1716 includes a flange attaching portion 1719 and a receptacleattaching portion 1720, and it houses a flange receiver 1717 and theflexible diaphragm 1704. The narrow end of the breast contacting flange1702 attaches to the flange receiver 1717, and the diaphragm 1704attaches to an opposite side of the flange receiver 1717. The adapter1716 connects via the bottle connector 1720 to the milk bottle 1718.Inside the adapter 1716, the flexible diaphragm 1704 includes an openingthrough which the pull rod 1706 extends and is attached. The pull rod1706 includes a proximal bulb 1708 and a distal bulb 1710. The flangeattaching portion 1719 of the adapter 1716, along with the flexiblediaphragm 1704, form a vacuum reservoir 1715.

A handle attachment portion 1714 is clamped over the pull rod and may bemoved from the position shown in FIG. 18A, where it resides between theproximal bulb 1708 and the distal bulb 1710, to a location on the otherside of the proximal bulb 1708 (to the right in FIG. 18A). Theattachment of the handle attachment portion 1714 to the pull rod 1706can best be seen in FIG. 18D. In this embodiment, the handle attachmentportion 1714 includes a slot into which the pull rod 1706 fits. Theillustrated position of the handle attachment portion 1714 on the pullrod 1706 may be used to create shorter pulls on the diaphragm 1704, forexample for stimulation of the breast, while the position farther to theright (farther proximally) along the pull rod 1706 may be used to createlarger pulls on the diaphragm 1704, for example for milk expression. Inuse, the woman presses the handle 1712 toward the bottle 1718, thuscausing the pull rod 1706 to pull on the diaphragm 1704, which causes asuction force on the breast via the breast contacting flange 1702. Asshown in FIGS. 18C and 18D, the bottle 1718 may optionally include fluidlevel markings 1722.

As with previously described embodiments, the flexible diaphragm 1704forms a one-way valve with the flange receiver 1717. The one-way valveallows expressed milk and/or colostrum to flow out of the narrow end ofthe breast contacting flange 1702 and into the milk bottle 1718 whensuction is applied, and then closes when suction is removed.

The above is meant to be a complete and accurate description of theinvention. The description provides examples, however, and theseexamples are not meant to be exhaustive. Alterations may be made to anyof the embodiments described above, without departing from the scope ofthe invention described by the claims below.

1-26. (canceled)
 27. A breastmilk collection device, comprising: aflange for accepting a breast; a vacuum reservoir; and a single flexiblediaphragm separating the flange from the vacuum reservoir; wherein thesingle flexible diaphragm is positioned in a sealed configuration, inwhich the flange is sealed off from the vacuum reservoir, and whereinthe single flexible diaphragm allows expressed breastmilk to flowthrough an opening formed by the single flexible diaphragm when anopening pressure is reached in the flange.
 28. The breastmilk collectiondevice of claim 27, wherein the single flexible diaphragm forms a planarsealing surface extending along an entire circumference of the singleflexible diaphragm.
 29. The breastmilk collection device of claim 27,further comprising a flange receiver defining a receiver openingtherethrough, wherein: a first end of the opening is in fluidcommunication with the flange; and a second end of the opening is sealedby the single flexible diaphragm.
 30. The breastmilk collection deviceof claim 29, wherein the single flexible diaphragm forms a planarsealing surface extending along an entire circumference of the flangereceiver.
 31. The breastmilk collection device of claim 30, wherein theopening through which the expressed breastmilk flows is formed betweenthe a portion of the single flexible diaphragm and a portion of theentire circumference of the flange receiver.
 32. The breastmilkcollection device of claim 29, wherein the flange receiver is coupled tothe flange.
 33. The breastmilk collection device of claim 27, furthercomprising a container for storing the expressed breastmilk.
 34. Thebreastmilk collection device of claim 27, wherein the flange includes awide portion for accepting the breast and a narrow portion extending tothe single flexible diaphragm.
 35. The breastmilk collection device ofclaim 27, wherein the single flexible diaphragm acts as a one-way valve.36. The breastmilk collection device of claim 27, wherein the singleflexible diaphragm both: (i) seals off the vacuum reservoir; and (ii)acts as a one-way valve to allow the expressed breastmilk to flow into acontainer for storage.
 37. A method of collecting breastmilk from abreast, the method comprising: positioning a flange of a breastmilkcollection device on the breast, wherein the breastmilk collectiondevice comprises: a vacuum reservoir; and a single flexible diaphragmseparating the flange from the vacuum reservoir; wherein the singleflexible diaphragm is positioned in a sealed configuration, in which theflange is sealed off from the vacuum reservoir, and wherein the singleflexible diaphragm allows expressed breastmilk to flow through anopening formed by the single flexible diaphragm when an opening pressureis reached in the flange.
 38. The method of claim 37, wherein the singleflexible diaphragm forms a planar sealing surface extending along anentire circumference of the single flexible diaphragm.
 39. The method ofclaim 37, wherein the breastmilk collection device further comprises aflange receiver defining a receiver opening therethrough, wherein: afirst end of the opening is in fluid communication with the flange; anda second end of the opening is sealed by the single flexible diaphragm.40. The method of claim 39, wherein the single flexible diaphragm formsa planar sealing surface extending along an entire circumference of theflange receiver.
 41. The method of claim 40, wherein the opening throughwhich the expressed breastmilk flows is formed between the a portion ofthe single flexible diaphragm and a portion of the entire circumferenceof the flange receiver.
 42. The method of claim 39, wherein the flangereceiver is coupled to the flange.
 43. The method of claim 37, whereinthe breastmilk collection device further comprises a container forstoring the expressed breastmilk.
 44. The method of claim 37, whereinthe flange includes a wide portion for accepting the breast and a narrowportion extending to the single flexible diaphragm.
 45. The method ofclaim 37, wherein the single flexible diaphragm acts as a one-way valve.46. The method of claim 37, wherein the single flexible diaphragm both:(i) seals off the vacuum reservoir; and (ii) acts as a one-way valve toallow the expressed breastmilk to flow into a container for storage.